FDA.reportPublic FDA data

RC NEEDLE

Primary DI
00880304463813
Brand
RC NEEDLE
Company
Biomet Orthopedics, LLC
Model
902963
Catalog number
902963
Published
2020-05-23
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
GABNEEDLE, SUTURING, DISPOSABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GABNeedle, Suturing, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00880304463813PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304463813008803044638138803044638130880304463813

GMDN Terms#

Term, Definition table
TermDefinition
Suturing needle, single-useA cylindrical-shaped, solid, metal instrument intended to be used to insert and pull suture material through tissue (e.g., skin, fascia, serous, vascular, or other tissue/organ) during surgical stitching of tissues. It is available in various lengths, curvatures, diameters, cross-sectional shapes, and distal end forms. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-9500customerservice@zimmerbiomet.com

Regulatory Flags#

DUNS number
129278169
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
00887868561368VersaNail®2810-13-0372810130372023-09-07
00889024707061A.L.P.S.®2142-35-0072142350072026-05-11
00889024707078DRILL BIT2312002012312002012026-05-11
00889024707085DRILL BIT8290-29-0708290290702026-05-11
00880304410541FIBER OPTICS FOR RC RETRACTOR9085349085342019-06-11
00880304321946BIFURCATED FIBER OPTIC CABLE31-55550231-5555022017-07-28
008803044639124MM X 9FT. LIGHT CABLE9061179061172017-07-28
00889024707054CALIBRATED DRILL BIT2142-27-0702142270702026-04-27
00880304233102Biomet® Knee System1418721418722015-10-24
00880304233126Biomet® Knee System1418741418742015-10-24
00880304233140Biomet® Knee System1418761418762015-10-24
00880304233164Biomet® Knee System1418781418782015-10-24
00880304233171Biomet® Knee System1418801418802015-10-24
00880304233188Biomet® Knee System1418821418822015-10-24
00880304433403Vanguard® Knee System1841441841442015-10-24
00880304433410Vanguard® Knee System1841811841812015-10-24
00880304433564Vanguard® Knee System1842851842852015-10-24
00880304433984Vanguard® Knee System1842801842802015-10-24
00880304434356Vanguard® Knee System1842651842652015-10-24
00880304434363Vanguard® Knee System1842701842702015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16931918121994AllesetGRI Medical & Electronic Technology Co., Ltd.GAB2026-04-06
16931918157016AllesetGRI Medical & Electronic Technology Co., Ltd.GAB2026-01-21
16931918179858AllesetGRI Medical & Electronic Technology Co., Ltd.GAB2025-06-21
16931918144948AllesetGRI Medical & Electronic Technology Co., Ltd.GAB2025-06-20
10192253052329DevonCardinal Health 200, LLCGAB2025-05-29
10192253052138DevonCardinal Health 200, LLCGAB2025-03-27
10192253052145DevonCardinal Health 200, LLCGAB2025-03-27
10192253052152DevonCardinal Health 200, LLCGAB2025-03-27
10192253052169DevonCardinal Health 200, LLCGAB2025-03-27
10192253052176DevonCardinal Health 200, LLCGAB2025-03-27
10192253052183DevonCardinal Health 200, LLCGAB2025-03-27
10192253052190DevonCardinal Health 200, LLCGAB2025-03-27
10192253052206DevonCardinal Health 200, LLCGAB2025-03-27
10192253052213DevonCardinal Health 200, LLCGAB2025-03-27
10192253052220DevonCardinal Health 200, LLCGAB2025-03-27
10192253052237DevonCardinal Health 200, LLCGAB2025-03-27
10192253052244DevonCardinal Health 200, LLCGAB2025-03-27
10192253052251DevonCardinal Health 200, LLCGAB2025-03-27
10192253052268DevonCardinal Health 200, LLCGAB2025-03-27
10192253052275DevonCardinal Health 200, LLCGAB2025-03-27
10192253052282DevonCardinal Health 200, LLCGAB2025-03-27
10192253052299DevonCardinal Health 200, LLCGAB2025-03-27
10192253052312DevonCardinal Health 200, LLCGAB2025-03-27
10192253052336DevonCardinal Health 200, LLCGAB2025-03-27
10192253052343DevonCardinal Health 200, LLCGAB2025-03-27
10192253052350DevonCardinal Health 200, LLCGAB2025-03-27
10192253052367DevonCardinal Health 200, LLCGAB2025-03-27
10192253052374DevonCardinal Health 200, LLCGAB2025-03-27
10192253052381DevonCardinal Health 200, LLCGAB2025-03-27
10192253053357DevonCardinal Health 200, LLCGAB2025-03-27