T2, PANGEA
- Primary DI
- 07613327649291
- Brand
- T2, PANGEA
- Company
- Stryker GmbH
- Model
- 6497-1-080
- Catalog number
- 6497-1-080
- Device description
- LATERAL NPCP, L
- Published
- 2025-09-25
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| HRS | Plate, fixation, bone |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | Orthopedic | 2 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 07613327649291 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 07613327649291 | 07613327649291 | 7613327649291 |
GMDN Terms#
| Term | Definition |
|---|---|
| Orthopaedic fixation plate, non-bioabsorbable | A non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws, and may be used in connection with another fixation plate; it does not incorporate a sleeve or blade. Disposable instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be packaged with the plate. |
Device Sizes#
| Type | Value | Unit |
|---|---|---|
| Device Size Text, specify | 0 | |
| Device Size Text, specify | 0 | |
| Length | 0 |
Sterilization Methods#
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags#
- DUNS number
- 481999654
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- 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
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 07613327697209 | PANGEA | SIT0007195 | SIT0007195 | 2026-08-27 |
| 07613327414127 | PANGEA | 706408S | 706408S | 2023-06-13 |
| 07613327415582 | PANGEA | 706407S | 706407S | 2023-06-13 |
| 07613327416138 | PANGEA | 706406S | 706406S | 2023-06-13 |
| 07613327539585 | PANGEA | 706444S | 706444S | 2023-06-13 |
| 07613327541731 | PANGEA | 703551S | 703551S | 2023-06-13 |
| 07613327541748 | PANGEA | 703555S | 703555S | 2023-06-13 |
| 07613154969357 | VARIAX | 45-35015S | 45-35015S | 2020-09-24 |
| 04546540195913 | NA | 1806-0083S | 1806-0083S | 2020-04-07 |
| 04546540195937 | NA | 1806-0085S | 1806-0085S | 2020-04-07 |
| 04546540195951 | NA | 1806-0090S | 1806-0090S | 2020-04-07 |
| 04546540195975 | NA | 1806-0093S | 1806-0093S | 2020-04-07 |
| 07613154633326 | NA | 45-20011S | 45-20011S | 2018-09-24 |
| 07613154633432 | NA | 45-30011S | 45-30011S | 2018-09-24 |
| 07613154665891 | NA | 45-20001S | 45-20001S | 2018-09-24 |
| 07613154665907 | NA | 45-20004S | 45-20004S | 2018-09-24 |
| 07613154665914 | NA | 45-30001S | 45-30001S | 2018-09-24 |
| 07613154665921 | NA | 45-30004S | 45-30004S | 2018-09-24 |
| 07613327083286 | AXSOS | 705077S | 705077S | 2016-09-24 |
| 07613327083323 | AXSOS | 705078S | 705078S | 2016-09-24 |
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