N/A
- Primary DI
- B5820303580
- Brand
- N/A
- Company
- GEORGE TIEMANN & CO.
- Model
- B5820303580
- Catalog number
- B5820303580
- Device description
- B5820303580
- Published
- 2020-09-24
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| EIG | RETRACTOR, ALL TYPES |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| EIG | Retractor, All Types | Dental | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| B5820303580 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Hand-held surgical retractor, reusable | A hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. This is a reusable device. |
Regulatory Flags
- DUNS number
- 107043630
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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| 00810042124868 | OSE | ORTHODONTIC SUPPLY & EQUIPMENT COMPANY INC | EIG | 2025-11-26 |
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| B382SD9147200610 | Surgical Direct | Surgical Direct, Inc. | EIG | 2025-09-12 |
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