FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 00889024376151
·
Model: 00-8851-002-07
·
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 00889024376151
- Version / Model
- 00-8851-002-07
- Catalog Number
- 00-8851-002-07
- Company Name
- ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.
- Labeler DUNS
- 137354267
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-02-15
- Public Version
- 4
- Public Version Date
- 2022-07-04
- Public Version Status
- Update
- Public Device Record Key
- 3e4f2b37-c980-4295-bf87-46b1a791ab3f
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 |
|---|---|---|---|---|
| GFD | DERMATOME | General, Plastic Surgery | 878.4820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37869 | Pneumatic surgical power tool hose | A single- or double-lumen (coaxial) tube in a straight or spiral design intended to be used to conduct compressed surgical-grade air or nitrogen (N2) gas from a gas source, usually the central medical gas supply system, to a surgical drilling system or sawing system handpiece or motor to supply it with power. The device is usually from 2 to 5 meters in length and is commonly designed according to ISO5359. The coaxial types have a double tube (inner and outer tubing) to facilitate the removal of the exhaust gases. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00889024376151 | GS1 |
Customer Contacts
- Phone
- +1(800)348-2759
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 3 Meter Length |