FDA.reportPublic FDA data

NA

Primary DI
00885556643747
Brand
NA
Company
Smith & Nephew, Inc.
Model
72204925
Catalog number
72204925
Device description
UNIVERSAL LIGHT GUIDE ORANGE 5MM X 12 FT
Published
2016-06-24
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
GJCASSAY, SULFHEMOGLOBIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GJCAssay, SulfhemoglobinHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K914919000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K914919000SMITH & NEPHEW DYONICS LAPAROSCOPY SYSTEMSmith & Nephew Dyonics, Inc.1992-01-09GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556643747PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556643747008855566437478855566437470885556643747

GMDN Terms#

Term, Definition table
TermDefinition
Fibreoptic light cableA flexible fibreoptic cable that is designed to transport cold light from a light source to an instrument or other equipment, e.g., an endoscope or a headlight. The fibreoptic bundle is protected within a sheath and can be made of either glass or plastic fibres. Each end of the cable is encased in a metal connector that fits into the respective instruments/equipment and also protects the end of the fibreoptic bundle. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization
Moist Heat or Steam Sterilization;Ethylene Oxide

Contacts#

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

Regulatory Flags#

DUNS number
045483575
Device count
1
Lot or batch
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00842180198579ELMEDELMED INCORPORATEDGJC2024-04-23
00842180198623ELMEDELMED INCORPORATEDGJC2024-04-23
00842180198630ELMEDELMED INCORPORATEDGJC2024-04-23
00842180175648ELMEDELMED INCORPORATEDGJC2023-08-08
00842180157699ELMEDELMED INCORPORATEDGJC2023-07-10
00842180167278ELMEDELMED INCORPORATEDGJC2023-04-17
00842180167285ELMEDELMED INCORPORATEDGJC2023-04-17
00842180167292ELMEDELMED INCORPORATEDGJC2023-04-17
00190776294892MillenniumAvalign Technologies, Inc.GJC2022-12-12
00190776296629MillenniumAvalign Technologies, Inc.GJC2022-12-12
00192896100831V.A.T.S. FOERSTER CLAMPSONTEC INSTRUMENTS, INC.GJC2020-02-24
04250480107614NASCHÖLLY FIBEROPTIC GmbHGJC2019-02-15
04042761010283OlympusOLYMPUS Winter & Ibe GmbHGJC2016-09-21
00385480420136STAT PROFILENOVA BIOMEDICAL CORPORATIONGJC2016-09-20
00385480420143STAT PROFILENOVA BIOMEDICAL CORPORATIONGJC2016-09-20
00385480420174STAT PROFILENOVA BIOMEDICAL CORPORATIONGJC2016-09-20
00385480420181STAT PROFILENOVA BIOMEDICAL CORPORATIONGJC2016-09-20
00385480485623STAT PROFILENOVA BIOMEDICAL CORPORATIONGJC2016-09-20
00385480485586STAT PROFILENOVA BIOMEDICAL CORPORATIONGJC2016-09-20
00385480485616STAT PROFILENOVA BIOMEDICAL CORPORATIONGJC2016-09-20
00385480485630STAT PROFILENOVA BIOMEDICAL CORPORATIONGJC2016-09-20
00385480485647STAT PROFILENOVA BIOMEDICAL CORPORATIONGJC2016-09-20
00385480485661Stat ProfileNOVA BIOMEDICAL CORPORATIONGJC2016-09-20
00385480485678STAT PROFILENOVA BIOMEDICAL CORPORATIONGJC2016-09-20
00385480485685STAT PROFILENOVA BIOMEDICAL CORPORATIONGJC2016-09-20
00385480485838STAT PROFILENOVA BIOMEDICAL CORPORATIONGJC2016-09-20
00385480485845STAT PROFILENOVA BIOMEDICAL CORPORATIONGJC2016-09-20
00385480485852Stat ProfileNOVA BIOMEDICAL CORPORATIONGJC2016-09-20
00385480485876Stat ProfileNOVA BIOMEDICAL CORPORATIONGJC2016-09-20