FDA.reportPublic FDA data

N/A

Primary DI
00885554033229
Brand
N/A
Company
Smith & Nephew, Inc.
Model
72204091
Catalog number
72204091
Device description
DRILL/REAMER
Published
2016-04-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWEINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885554033229PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885554033229008855540332298855540332290885554033229

GMDN Terms#

Term, Definition table
TermDefinition
Battery boxA special container intended to be used to house batteries for protective purposes. This device will typically be portable so that the user can safely carry the power source.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
045483575
Device count
1
Premarket exempt
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885554009101NA720770572077052015-08-30
00885556925690NAROB30080ROB300802026-06-04
03596010589101JOURNEY71422274714222742015-08-30
03596010589132JOURNEY71422277714222772015-08-30
03596010000675OXINIUM71343603713436032015-08-30
03596010474148OXINIUM71342800713428002015-08-30
03596010474162OXINIUM71342804713428042015-08-30
03596010474179OXINIUM71342808713428082015-08-30
03596010474209OXINIUM71343200713432002015-08-30
03596010474216OXINIUM71343203713432032015-08-30
03596010474223OXINIUM71343204713432042015-08-30
03596010474230OXINIUM71343208713432082015-08-30
03596010477279OXINIUM71343600713436002015-08-30
03596010477286OXINIUM71343604713436042015-08-30
03596010477293OXINIUM71343608713436082015-08-30
03596010488862OXINIUM71342200713422002015-08-30
03596010544193JOURNEY71461012714610122015-08-30
03596010544209JOURNEY71461013714610132015-08-30
03596010544216JOURNEY71461014714610142015-08-30
03596010544223JOURNEY71461015714610152015-08-30

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Primary DI, Brand, Company table
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00842078130315CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078130452CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078130490CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078130537CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078134054CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078134061CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078134078CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078134085CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078134092CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078134108CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078134115CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
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10705034647807TRIALTISMedos International SàrlHWE2026-06-03
10705034647814TRIALTISMedos International SàrlHWE2026-06-03
10705034647821TRIALTISMedos International SàrlHWE2026-06-03
10705034647838TRIALTISMedos International SàrlHWE2026-06-03
10705034648118TRIALTISMedos International SàrlHWE2026-06-03
00810111227292K-WireTreace Medical Concepts, Inc.HWE2026-06-02
07613327648331PANGEAStryker GmbHHWE2026-06-02
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07613327652710PROstepSTRYKER CORPORATIONHWE2026-04-13
07613327652727N/ASTRYKER CORPORATIONHWE2026-04-13
07613327652734N/ASTRYKER CORPORATIONHWE2026-04-13
07613327652741N/ASTRYKER CORPORATIONHWE2026-03-25
07613327652758N/ASTRYKER CORPORATIONHWE2026-03-25