FDA.reportPublic FDA data

Burch-Schneider™

Primary DI
00889024279025
Brand
Burch-Schneider™
Company
Zimmer GmbH
Model
01.00199.004
Catalog number
01.00199.004
Published
2020-06-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZOCHISEL, SURGICAL, MANUAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZOChisel, Surgical, ManualGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024279025PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024279025008890242790258890242790250889024279025

GMDN Terms#

Term, Definition table
TermDefinition
Joint prosthesis implantation kit, reusableA collection of surgical instruments used for cutting and forming bone to allow the implantation of a joint prosthesis. The instruments include various metallic and/or plastic reusable devices (e.g., retractors, rods, clamps, drills, pins, saws, guides, cutting blocks) that are specific to the joint of application (e.g., hip, knee, shoulder, ankle, or elbow); the implant(s) is not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-2759zimmer.consumerrelations@zimmerbiomet.com

Regulatory Flags#

DUNS number
488133448
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887868453120Avenir®01.08000.01201.08000.0122021-02-25
00889024298521Natural Nail®47-2487-002-0047-2487-002-002015-10-21
00889024298538Natural Nail®47-2487-002-0547-2487-002-052015-10-21
00889024298545Natural Nail®47-2487-002-1047-2487-002-102015-10-21
00889024298552Natural Nail®47-2487-002-1547-2487-002-152015-10-21
00889024292512NCB®02.02261.0132024-05-03
00889024292550NCB®02.02261.1132024-05-03
00889024296558NCB®02.03156.0902024-05-03
00889024296565NCB®02.03156.0952024-05-03
00889024296572NCB®02.03156.1002024-05-03
00889024506503Affixus® Natural Nail®1100356641100356642019-03-21
00889024506510Affixus® Natural Nail®1100372371100372372019-03-21
00889024506527Affixus® Natural Nail®1100356651100356652019-03-21
00889024506534Affixus® Natural Nail®1100356661100356662019-03-21
00889024506558Affixus® Natural Nail®1100356681100356682019-03-21
00889024277038Dynesys® Top-Loading System01.03956.4502015-10-16
00889024283688Dynesys®01.03710.0062015-10-16
00889024283695Dynesys®01.03710.6452016-03-14
00889024283701Dynesys®01.03711.1002016-03-14
00889024283718Dynesys®01.03711.2002016-03-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04054896001753ChiselSilony Medical GmbHFZO2026-09-18
04054896001760ChiselSilony Medical GmbHFZO2026-09-18
04054896001777ChiselSilony Medical GmbHFZO2026-09-18
04054896005751ChiselSilony Medical GmbHFZO2026-09-18
04054896018430ChiselSilony Medical GmbHFZO2026-09-18
04054896018447ChiselSilony Medical GmbHFZO2026-09-18
04054896050652ChiselSilony Medical GmbHFZO2026-09-18
04054896050669ChiselSilony Medical GmbHFZO2026-09-18
04054896050676ChiselSilony Medical GmbHFZO2026-09-18
04054896050683ChiselSilony Medical GmbHFZO2026-09-18
04054896050690ChiselSilony Medical GmbHFZO2026-09-18
04054896050706ChiselSilony Medical GmbHFZO2026-09-18
04054896051284ChiselSilony Medical GmbHFZO2026-09-18
04054462907663evonosevonos GmbH & Co. KGFZO2026-08-21
04054462912162evonosevonos GmbH & Co. KGFZO2026-08-19
04054462912179evonosevonos GmbH & Co. KGFZO2026-08-19
04054462912803evonosevonos GmbH & Co. KGFZO2026-08-19
04054462912810evonosevonos GmbH & Co. KGFZO2026-08-19
04054462905416evonosevonos GmbH & Co. KGFZO2026-08-18
04054462905423evonosevonos GmbH & Co. KGFZO2026-08-18
04054462905430evonosevonos GmbH & Co. KGFZO2026-08-18
04054462905447evonosevonos GmbH & Co. KGFZO2026-08-18
04054462905461evonosevonos GmbH & Co. KGFZO2026-08-18
04054462905478evonosevonos GmbH & Co. KGFZO2026-08-18
04054462905485evonosevonos GmbH & Co. KGFZO2026-08-18
04054462905492evonosevonos GmbH & Co. KGFZO2026-08-18
04054462905508evonosevonos GmbH & Co. KGFZO2026-08-18
04054462905515evonosevonos GmbH & Co. KGFZO2026-08-18
04054462905522evonosevonos GmbH & Co. KGFZO2026-08-18
04054462907632evonosevonos GmbH & Co. KGFZO2026-08-18