Identity
- Trade Name
- ACE FDA UDI
- Generic Name
- Hand-held dental retractor FDA UDI
- Device Name
- SPREADER JAW MAUNDER SCREW PLASTIC 2-1/4" 5.5CM FDA UDI
- Model / Reference
- 0100063 FDA UDI
- Description
- SPREADER JAW MAUNDER SCREW PLASTIC 2-1/4" 5.5CM FDA UDI
Identifiers
- Catalog Number
- 0100063 FDA UDI
- Primary DI / UDI-DI
- 00614950017157 FDA UDI
- FDA Product Code
- EIG FDA UDI
- GMDN Term
- Hand-held dental retractor FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 2.25 Inch FDA UDI
Category: Hand-held dental retractor
Ace by Ace Surgical Supply Co., Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hand-held dental retractor.
- Power Dental USA — Power Dental USA, Inc. · Class I
- Tatum Sinus Retractor — SUNCOAST DENTAL, INC. · Class I
- devemed — devemed GmbH · Class I
- STOMA® — Storz am Mark GmbH · Class I
- DIOnavi. Scan Retractor Lower jaw — DIO Corporation · Class I
- EXPANDER — KLS-Martin L.P. · Class I
- PILLING — TELEFLEX INCORPORATED · Class I
- BMT Medizintechnik GmbH — BMT Medizintechnik GmbH · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ace Surgical Supply Co., Inc.
Sources (1)
- FDA UDI ffa41dbe-2e02-44e1-b3e8-c3f8637072e7 37 fields · synced Jun 1, 2026