FDA UDI
In Commercial Distribution
🇺🇸 United States
Ambler Surgical
DI: 00190660068752
·
Model: Wolff plaster cast breaker
·
AMBLER SURGICAL CORP.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Ambler Surgical
- Primary DI
- 00190660068752
- Version / Model
- Wolff plaster cast breaker
- Catalog Number
- 32-732
- Company Name
- AMBLER SURGICAL CORP.
- Labeler DUNS
- 015272206
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-01-04
- Public Version
- 2
- Public Version Date
- 2022-08-30
- Public Version Status
- Update
- Public Device Record Key
- 92d9e8bb-becd-4710-920e-b8af05f9bfd7
Device Description
Wolff plaster cast breaker, 9 1/2''
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEN | FORCEPS, GENERAL & PLASTIC SURGERY | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13708 | Cast spreader, reusable | A hand-operated instrument with specially designed blades intended to separate and spread hardened plaster, i.e., plaster that has already formed a cast around a patient's limb or body part. It is designed like large forceps with flat, outer-edge serrated blades that may be exchangeable and which are wedge-shaped (thin at the working end). The blades are intended to be prised between cut plaster so that when the device handles are squeezed the cast separates. It is typically made of high-grade stainless steel. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00190660068752 | GS1 |
Customer Contacts
- Phone
- +1(888)407-0006 ext. 0
- [email protected]