Identity
- Trade Name
- JMU FDA UDI
- Generic Name
- Sterilization packaging, single-use FDA UDI
- Device Name
- Autoclave Sterilization Wrap Sheets (CSR), crepe paper, 60grams, 15"x15", blue, 100pcs/bag, 1000pcs/case (38*38cm) FDA UDI
- Model / Reference
- 32116001 FDA UDI
- Description
- Autoclave Sterilization Wrap Sheets (CSR), crepe paper, 60grams, 15"x15", blue, 100pcs/bag, 1000pcs/case (38*38cm) FDA UDI
Identifiers
- Primary DI / UDI-DI
- D930321160010 FDA UDI
- 510(k) Number
- K181957 FDA UDI
- FDA Product Code
- FRG 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
- Not 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
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
Jmu by Jmu Dental, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K181957 also covers:
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
- Jmu Dental, Inc
Sources (1)
- FDA UDI c03fb783-2870-4aac-ae5b-a58fbcec7456 35 fields · synced May 30, 2026