FDA.reportPublic FDA data

Sterile Pin-Kaps

Primary DI
00690521023710
Brand
Sterile Pin-Kaps
Company
Batrik Medical Manufacturing Inc
Model
C1091
Catalog number
C1091
Device description
"Pin Kaps 7/64"" 2.77mm Tan"
Published
2024-07-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00690521023833PackageGS180In Commercial Distribution
00690521023710PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00690521023833006905210238336905210238330690521023833
00690521023710006905210237106905210237100690521023710

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument guard, single-useA device designed to be used with a surgical or invasive instrument to protect the instrument from damage and/or the operator or patient from injury. It is typically made of metal or plastic materials and available in a variety of designs. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep at ambient temperature and away from direct sunlight
Special Storage Condition, Specify00Keep Dry

Contacts#

Phone, Email table
PhoneEmail
514-631-7988info@surgmed.com

Regulatory Flags#

DUNS number
243880700
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00690521025196EcoZyme First Touch19560-TS19560-TS2025-07-11
00690521025226EcoZyme First Touch19560-FS19560-FS2025-07-11
00690521025257EcoZyme First Touch19560-TS50019560-TS5002025-07-11
00690521025271EcoZyme First Touch19560-TS22019560-TS2202025-07-11
00690521025295EcoZyme First Touch19560-FS50019560-FS5002025-07-11
00690521025318EcoZyme First Touch19560-FS22019560-FS2202025-07-11
00690521025332EcoZyme First Touch19560-TS-BAG19560-TS-BAG2025-07-10
00690521015012Batrik Your First Check17-22217-2222025-07-11
00690521015876Batrik Your First Check17-22217-2222025-07-11
00690521025202EcoZyme First Touch19560-TS19560-TS2025-07-11
00690521025233EcoZyme First Touch19560-FS19560-FS2025-07-11
00690521025264EcoZyme First Touch19560-TS50019560-TS5002025-07-11
00690521025288EcoZyme First Touch19560-TS22019560-TS2202025-07-11
00690521025301EcoZyme First Touch19560-FS50019560-FS5002025-07-11
00690521025325EcoZyme First Touch19560-FS22019560-FS2202025-07-11
00690521014855Batrik Your First Check Cylindrical Sponge w/Enz. Sol17-11117-111, 19560-TS-BAG2022-01-27
00690521019201Batrik ShoozCovers™ SC-1216-PDBSC-1216-PDB2025-02-14
00690521019218Batrik ShoozCovers™ SC-1226-PDBSC-1226-PDB2025-02-14
00690521020948Batrik ShoozCovers™ SC-1210-PBSC-1210-PB2025-02-14
00690521020955Batrik ShoozCovers™ SC-1616-PDBSC-1616-PDB2025-02-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995323592V. MuellerSTERIS Deutschland GmbHLXH2026-09-25
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00840606186230ALIF Disc PrepSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186261ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186278ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186285ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606187381ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00843193112699Prodisc C InstrumentCentinel Spine, LLCLXH2026-09-25
00843193112705Prodisc C InstrumentCentinel Spine, LLCLXH2026-09-25
07630040795166Surgical Manual InstrumentMedacta International SALXH2026-09-25
07630542792359Surgical Manual InstrumentMedacta International SALXH2026-09-25
20845854655501Argo KnotlessConmed CorporationLXH2026-09-25
20845854655518Argo KnotlessConmed CorporationLXH2026-09-25
00810130207541MSIModern Surgical Instruments LLCLXH2026-09-24
00810130207558MSIModern Surgical Instruments LLCLXH2026-09-24
00840606185929PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606185936PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606186773PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606186780PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187237PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187244PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187251PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00885556854778Cadence Total Ankle SystemSmith & Nephew, Inc.LXH2026-09-24
07899258601670Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-09-24
B7685215250Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2026-06-19
B7683434130Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2026-04-23
B7685216220Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-13
B7685111560Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03
B768521135180Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03
B7685216060Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03