Identity
- Trade Name
- SLM FDA UDI
- Generic Name
- Mechanical pipette FDA UDI
- Device Name
- Blastomere Biopsy Pipette FDA UDI
- Model / Reference
- SBB-20X-35 FDA UDI
- Description
- Blastomere Biopsy Pipette FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10816633023128 FDA UDI
- 510(k) Number
- K092554 FDA UDI
- FDA Product Code
- PUC FDA UDI
- GMDN Term
- Mechanical pipette FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.6130 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Mechanical pipette
Slm by Sunlight Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Mechanical pipette.
- Wallace — ICU MEDICAL, INC. · Class II
- Wallace — ICU MEDICAL, INC. · Class II
- Wallace — ICU MEDICAL, INC. · Class II
- LabChoice Mechanical Pipette, Single Channel, Adjustable Volume 0.5 - 5 ML — Dynarex Corp. · Class I
- Sunbiotec — Hubei Huamei Sunlight Biotechnologies Co., Ltd · Class II
- Wallace — ICU MEDICAL, INC. · Class II
- Wallace — ICU MEDICAL, INC. · Class II
- Wallace — ICU MEDICAL, INC. · Class II
Cleared under the same submission
K092554 also covers:
- SLM — Sunlight Medical, Inc.
- SLM — Sunlight Medical, Inc.
- SLM — Sunlight Medical, Inc.
- SLM — Sunlight Medical, Inc.
- SLM — Sunlight Medical, Inc.
- SLM — Sunlight Medical, Inc.
- SLM — Sunlight Medical, Inc.
- SLM — Sunlight Medical, Inc.
- SLM — Sunlight Medical, Inc.
- SLM — Sunlight Medical, Inc.
- SLM — Sunlight Medical, Inc.
- SLM — Sunlight Medical, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sunlight Medical, Inc.
Sources (1)
- FDA UDI f587cf95-74c4-4bb2-8183-564637e37328 35 fields · synced Jun 9, 2026