Identity
- Trade Name
- Fisherbrand FDA UDI
- Generic Name
- Sterilization packaging, single-use FDA UDI
- Device Name
- 10X15INSLF SEL ATCLV PCH 100PK FDA UDI
- Model / Reference
- SCLF1015 FDA UDI
- Description
- 10X15INSLF SEL ATCLV PCH 100PK FDA UDI
Identifiers
- Catalog Number
- 0181257 FDA UDI
- Primary DI / UDI-DI
- 00613647000007 FDA UDI
- 510(k) Number
- K941327 FDA UDI
- FDA Product Code
- KCT FDA UDI
- GMDN Term
- Sterilization packaging, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6850 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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: Sterilization packaging, single-use
Fisherbrand by Fisher Scientific Company L.l.c. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K941327 also covers:
- Treo — BENCO DENTAL SUPPLY CO.
- Treo — BENCO DENTAL SUPPLY CO.
- Burkhart Select Multivariable Sterilezation Pouch 3 1/2 x 5 1/4 (200) — BURKHART DENTAL SUPPLY CO., THE
- Burkhart Select Multivariable Sterilization Pouch 3-1/2 x 9 (200) — BURKHART DENTAL SUPPLY CO., THE
- Burkhart Select Multivariable Sterilization Pouch 5 1/4X10 (200) — BURKHART DENTAL SUPPLY CO., THE
- Burkhart Sterile Pouches 2-1/4"X4" 200/pkg — BURKHART DENTAL SUPPLY CO., THE
- Burkhart Sterile Pouches 2-3/4"X10" 200/pkg — BURKHART DENTAL SUPPLY CO., THE
- Burkhart Sterile Pouches 3-1/2"X5-1/4" 200/pkg — BURKHART DENTAL SUPPLY CO., THE
- Burkhart Sterile Pouches 7-1/2" x 13" (200) — BURKHART DENTAL SUPPLY CO., THE
- Fisherbrand — FISHER SCIENTIFIC COMPANY L.L.C.
- Fisherbrand — FISHER SCIENTIFIC COMPANY L.L.C.
- Henry Schein — HENRY SCHEIN, 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 |
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Manufacturer
- Manufacturer
- Fisher Scientific Company L.l.c.
Sources (1)
- FDA UDI b79b23c5-fa3b-4939-8f65-0b2ee2283985 36 fields · synced May 31, 2026