FDA.reportPublic FDA data

SCP 3.2mm Blade Pin

Primary DI
00889024205109
Brand
SCP 3.2mm Blade Pin
Company
Zimmer Knee Creations, Inc.
Model
303.232
Catalog number
303.232
Published
2016-05-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXKHolder, Needle; Orthopedic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXKHolder, Needle; OrthopedicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024205109PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024205109008890242051098890242051090889024205109

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic trocar blade, reusableA rigid hand-held surgical instrument with a sharp (pyramidal or conical) point designed to be used during orthopaedic surgery for the manual puncture of a bodily entry point to: 1) gently part the surrounding soft tissue upon entry; 2) assist in the location and positioning of skeletal fractures; and/or 3) assist alignment of surgical instruments/implants. It is typically made of high-grade stainless steel, titanium (Ti), or synthetic material. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter3.2Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
484-887-8902KC.Customerservice@zimmerbiomet.com

Regulatory Flags#

DUNS number
078836317
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024205192AccuPort® Cannula 308.081308.0812016-05-18
00889024205208AccuPort® Cannula 308.082308.0822016-05-18
00889024686915SCP®4643022025-07-03
00889024686922SCP®4643032025-07-03
00889024686939SCP®4645022025-07-03
00889024686946SCP®4645032025-07-03
00889024686953SCP®5141532025-07-03
00889024686960SCP®6643412025-07-03
00889024686977SCP®6645842025-07-03
00889024205253SCP402.2012015-10-23
00889024205260Subchondroplasty® Knee Kit402.2022015-10-23
00889024205277Subchondroplasty® Knee Kit402.2032015-10-23
00889024205314SCP® Knee Kit414.5022015-10-23
00889024205321SCP® Knee Kit414.5032015-10-23
00889024205338SCP® Foot & Ankle Kit514.3022015-10-23
00889024205345SCP® Foot & Ankle Kit514.3032015-10-23
00889024205352SCP® Foot & Ankle Kit514.3152015-10-23
00889024205369SCP® Foot & Ankle Kit514.5022015-10-23
00889024205376SCP® Foot & Ankle Kit514.5032015-10-23
00889024205383SCP614.5812015-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995268916Snowden-PencerSTERIS Deutschland GmbHHXK2026-09-25
00724995268923Snowden-PencerSTERIS Deutschland GmbHHXK2026-09-25
00724995268930Snowden-PencerSTERIS Deutschland GmbHHXK2026-09-25
00724995268947Snowden-PencerSTERIS Deutschland GmbHHXK2026-09-25
00724995268954Snowden-PencerSTERIS Deutschland GmbHHXK2026-09-25
00724995268961Snowden-PencerSTERIS Deutschland GmbHHXK2026-09-25
00724995268978Snowden-PencerSTERIS Deutschland GmbHHXK2026-09-25
04054462904747evonosevonos GmbH & Co. KGHXK2026-08-21
04054462904754evonosevonos GmbH & Co. KGHXK2026-08-21
04054462904761evonosevonos GmbH & Co. KGHXK2026-08-21
04054462904778evonosevonos GmbH & Co. KGHXK2026-08-21
04054462904785evonosevonos GmbH & Co. KGHXK2026-08-21
04054462904792evonosevonos GmbH & Co. KGHXK2026-08-21
00850088713428PRINCETONPrinceton Medical Group, Inc.HXK2026-08-14
04058749047196NAFehling Instruments GmbH & Co. KGHXK2026-07-17
04058749117387NAFehling Instruments GmbH & Co. KGHXK2026-07-17
00850083275235Intrace USAPILOTIS TECH LLCHXK2026-07-03
00850083275594Intrace USAPILOTIS TECH LLCHXK2026-07-03
00850083275945Intrace USAPILOTIS TECH LLCHXK2026-07-03
00850083275952Intrace USAPILOTIS TECH LLCHXK2026-07-03
04052536078349neon3Ulrich GmbH & Co. KGHXK2026-06-09
04052536078356neon3Ulrich GmbH & Co. KGHXK2026-06-09
04052536078363neon3Ulrich GmbH & Co. KGHXK2026-06-09
04052536169931neon3Ulrich GmbH & Co. KGHXK2026-06-09
04052536161997neon3Ulrich GmbH & Co. KGHXK2026-06-08
00810158219625PRINCETONPrinceton Medical Group, Inc.HXK2026-04-22
00810158216778PRINCETONPrinceton Medical Group, Inc.HXK2026-04-20
04058749119695NAFehling Instruments GmbH & Co. KGHXK2025-12-08
09348811016249INKAThe Trustee for KAISER FAMILY TRUSTHXK2025-11-19
09348811016379INKAThe Trustee for KAISER FAMILY TRUSTHXK2025-11-19