Chrysalis Intelligence · Product Codes · MSC

MSC · Barrier, Std, Oral Sex

Obstetrics/Gynecology · 4 clearances · 4 unique sponsors

Device class
Class II
Regulation 884.5300
Total clearances
4
2021-08-05 → 2026-07-14
Last 12 months
1
Unique sponsors
4
Medical specialty
Obstetrics/Gynecology
Review panel
OB
Regulation number
884.5300
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
Y
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Pamco Distributing, Inc. 1 0 2021-08-05
Brazen Goods Inc. Dba Lorals 1 0 2022-04-22
Luwi, LLC 1 1 2026-07-14
Sanctuary Health Sdn. Bhd. 1 0 2022-03-28
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
99072 CPT Low Not directly billable as procedure code; typically part of contraceptive supplies or patient education materials
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-07-14 K253662 Luwi, LLC LIXI (LXOSFM1)
2022-04-22 K212928 Brazen Goods Inc. Dba Lorals Lorals
2022-03-28 K212037 Sanctuary Health Sdn. Bhd. SancDam Latex Oral Dam
2021-08-05 K203727 Pamco Distributing, Inc. Harmony Latex Dam, Harmony Non-Latex Dam