FDA.report

Anthology

Primary DI
00885556761007
Brand
Anthology
Company
Smith & Nephew, Inc.
Model
71365309
Catalog number
71365309
Device description
ANTHOLOGY BROACH i SIZE 9
Published
2020-07-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HTQBROACH

Product Code Classifications

CodeDeviceSpecialtyClass
HTQBroachOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00885556761007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556761007008855567610078855567610070885556761007

GMDN Terms

TermDefinition
Orthopaedic broachA surgical instrument that is designed as an elongated, tapered and serrated cutting tool intended for shaping and enlarging holes in bone tissue. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags

DUNS number
109903521
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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00885556884034NA74038835740388352026-02-20
00885556884140NA74038846740388462026-02-20

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