FDA UDI
In Commercial Distribution
🇺🇸 United States
GIRO GROWTH MODULATION SYSTEM
DI: 07540194014702
·
Model: GRO-A60-036
·
Pega Medical Inc
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- GIRO GROWTH MODULATION SYSTEM
- Primary DI
- 07540194014702
- Version / Model
- GRO-A60-036
- Catalog Number
- GRO-A60-036
- Company Name
- Pega Medical Inc
- Labeler DUNS
- 257315713
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-11-24
- Public Version
- 1
- Public Version Date
- 2023-12-04
- Public Version Status
- New
- Public Device Record Key
- e7cdb6d3-0c49-46e6-9f43-da6b90a42f08
Device Description
6.0 GIRO 36mm
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| OBT | Plate, bone, growth control, pediatric, epiphysiodesis | Orthopedic | 888.3030 | 2 |
| HWC | Screw, fixation, bone | Orthopedic | 888.3040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46647 | 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; it does not incorporate a sleeve or blade. Instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be included with the plate. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07540194014702 | GS1 |
Customer Contacts
- Phone
- +1(450)688-5144 ext. 242
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K220190 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 36 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- keep at room temperature