FDA.reportPublic FDA data

ExpressBraid™ Graft Manipulation

Primary DI
00887868462566
Brand
ExpressBraid™ Graft Manipulation
Company
Biomet Orthopedics, LLC
Model
110003464
Catalog number
110003464
Published
2021-07-19
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
GATSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GATSuture, Nonabsorbable, Synthetic, PolyethyleneGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152868000
K163651000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152868000ExpressBraid Graft ManipulationBiomet Manufacturing Corp2016-02-08GAT
K163651000ExpressBraid Graft ManipulationBiomet Manufacturing Corp2017-02-17GAT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887868462566PrimaryGS10
70887868462565Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887868462566008878684625668878684625660887868462566
7088786846256570887868462565

GMDN Terms#

Term, Definition table
TermDefinition
Operative-site suture holderA device designed to hold suture threads to facilitate their manipulation, positioning and differentiation around the operative site during a surgical procedure. It typically has a circular, oval, or curved shape with grooves or other connecting elements, and is stabilized by attachment to a surgical drape; it may also be attached to an invasive surgical retractor. This is a single-use device.

Device Sizes#

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

Contacts#

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

Regulatory Flags#

DUNS number
129278169
Device count
10
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00880304737488Cartridge Thread Adapter1100301661100301662020-02-13
05019279925377Cobalt MV Bone Cement4024384024382015-11-28
00880304370456CEMENT NOZZLE4149914149912017-07-28
00880304370517OPTIVAC415441542017-07-28
00880304476783Cobalt MV with Gentamicin4024394024392015-11-28
00880304560789Cobalt Bone Cement4022824022822015-11-28
00880304560796Cobalt HV with Gentamicin4022834022832015-11-28
00887868494758Vanguard® Instruments32-48625932-4862592022-05-25
00888480584162PRO OSTEON 2002B0402B0402015-10-24
00888480584179PRO OSTEON 2002B0452B0452015-10-24
00888480584186PRO OSTEON 2002B0752B0752015-10-24
00888480584247PRO OSTEON 2002G022G022015-10-24
00888480584254PRO OSTEON 2002G052G052015-10-24
00888480584339PRO OSTEON 200R2RG0052RG0052015-10-24
00888480584346PRO OSTEON 200R2RG022RG022015-10-24
00888480584353PRO OSTEON 200R2RG052RG052015-10-24
00888480584360PRO OSTEON 200R2RG152RG152015-10-24
00888480584476PRO OSTEON 5005B0405B0402015-10-24
00888480584483PRO OSTEON 5005B0755B0752015-10-24
00888480584490PRO OSTEON 5005B1005B1002015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04038653900497PremicronB BRAUN SURGICAL SAGAT2015-11-11
04038653914050PremicronB BRAUN SURGICAL SAGAT2015-11-05
04038653921980PremicronB BRAUN SURGICAL SAGAT2015-11-05
04038653991822PremicronB BRAUN SURGICAL SAGAT2015-11-05
04045439003853PremicronB BRAUN SURGICAL SAGAT2015-11-05
04045439003914PremicronB BRAUN SURGICAL SAGAT2015-11-05
04045439003921PremicronB BRAUN SURGICAL SAGAT2015-11-05
04045439020690PremicronB BRAUN SURGICAL SAGAT2015-11-05
04038653991785PremicronB BRAUN SURGICAL SAGAT2015-11-05
04038653983919PremicronB BRAUN SURGICAL SAGAT2015-08-27
04038653983544PremicronB BRAUN SURGICAL SAGAT2015-08-27
04038653750337PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653750450PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653871230PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653900480PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653900695PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653900701PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653900725PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653911035PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653922246PremicronB BRAUN SURGICAL SAGAT2015-08-26
04045439000944PremicronB BRAUN SURGICAL SAGAT2015-08-26
04045439001002PremicronB BRAUN SURGICAL SAGAT2015-08-26
04045439059072PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653900503PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653900510PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653900732PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653988402PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653951048PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653900541PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653900534PremicronB BRAUN SURGICAL SAGAT2015-08-26