FDA UDI
In Commercial Distribution
🇺🇸 United States
MaxTack
DI: 10884521826267
·
Model: MAXTACK30
·
Covidien LP
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- MaxTack
- Primary DI
- 10884521826267
- Version / Model
- MAXTACK30
- Company Name
- Covidien LP
- Labeler DUNS
- 058614483
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-09-09
- Public Version
- 3
- Public Version Date
- 2025-06-24
- Public Version Status
- Update
- Public Device Record Key
- d2322aed-dd3d-4044-bbbf-54d05ea25275
Device Description
Motorized Fixation Device 30 Absorbable Tacks
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
- Yes
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OCW | Endoscopic tissue approximation device | Gastroenterology, Urology | 876.1500 | 2 |
| GDW | Staple, implantable | General, Plastic Surgery | 878.4750 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 67035 | Soft-tissue repair material fixation tack | An implantable bioabsorbable device intended to be used for the fixation of soft-tissue repair material (e.g., prosthetic silicone sheet, surgical mesh) during surgical repair and reconstruction of soft-tissue defects (e.g., ventral and groin hernia). It is not designed for dental or ophthalmic applications. It is in the form of a small cylinder with a rounded head and a tapered end made of synthetic polymer materials; it is available independently or preloaded in a disposable implantation device (e.g., motorized handpiece). | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20884521826264 | GS1 | PACK_OR_INNER_PACK | 6 | In Commercial Distribution | |
| Primary | 10884521826267 | GS1 |
Customer Contacts
- Phone
- +1(508)261-8000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K231240 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 5 | Millimeter |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- – 118 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- – 118 Degrees Fahrenheit
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 55 – 101 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- – 90 Percent (%) Relative Humidity