FDA.reportPublic FDA data

Stripper

Primary DI
10810190018290
Brand
Stripper
Company
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
Model
B
Catalog number
lt166100
Published
2016-09-24
Public version status
Update
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 table
CodeName
HRTStripper, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRTStripper, SurgicalOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810190018290PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081019001829010810190018290

GMDN Terms#

Term, Definition table
TermDefinition
Tendon stripperA hand-held manual surgical instrument designed to excise a length of ligament, tendon or fascia for use as a living graft. It typically consists of a handle and a semicircular shaped trough that terminates in a sharp cutting edge. It is typically made of high-grade stainless steel. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
534123013
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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10810128461815GFS Subscapularis Spreader3910-800-019la524HB001st2026-01-18
10810128461822GFS Glenoid Drill3910-800-020la524130st2026-01-18
10810128461839GFS Glenoid Guide3910-800-021la524v00st2026-01-18
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10810128461655GFS Switching Stick3910-800-003la900130st2026-01-15
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10810128461679GFS Coracoid Drill3910-800-005la524p01st2026-01-15
10810128461686GFS Coracoid Top Hat Drill3910-800-006la524p00st2026-01-15
10810128461693GFS Top Hat Tap3910-800-007la524400st2026-01-15
10810128461709GFS Sharp Curved Osteotome3910-800-008la524800st2026-01-15
10810128461716GFS Subscapularis Channeler3910-800-009la524900st2026-01-15
10810128461747GFS Glenoid Offset Pin3910-800-012la524u00st2026-01-15
10810128461754GFS Coracoid Screw, 3.5mm3910-800-013la524f00st2026-01-15

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