FDA UDI
In Commercial Distribution
🇺🇸 United States
HEX GROOVED KLS OSTEOTOME EPKER, STRAIGHT, 4MM, 18CM
DI: D9289196040
·
Model: 91-9604
·
W.H. Holden, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HEX GROOVED KLS OSTEOTOME EPKER, STRAIGHT, 4MM, 18CM
- Primary DI
- D9289196040
- Version / Model
- 91-9604
- Catalog Number
- 91-9604
- Company Name
- W.H. Holden, Inc.
- Labeler DUNS
- 183854322
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-14
- Public Version
- 1
- Public Version Date
- 2024-08-22
- Public Version Status
- New
- Public Device Record Key
- 3e1e3ea3-fa98-4bce-a433-67f39a500712
Device Description
HEX GROOVED KLS OSTEOTOME EPKER, STRAIGHT, 4MM, 18CM
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| GFI | Osteotome, Manual | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44887 | Dental osteotome | A hand-held, dental, surgical instrument used during dental osteotomy for shaping and condensing bone, typically when performing a dental implant surgical procedure. It is hand-held by the dentist who will use a surgical mallet or hammer to manually impart an impacting force to the proximal end of the instrument. The device will have a straight or bayonet-shaped handle leading to a round or concave tip at the distal end, which may be marked with graduations to indicate depth differences. It is used for ridge expanding, bone condensing and sinus floor elevation procedures. This device will be 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 | D9289196040 | HIBCC |