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
03596010482280CLEAR-TRAC721012172101212015-10-22
03596010532619NA721071972107192015-08-30
03596010505132SCULPTOR721069772106972015-08-30
03596010505149SCULPTOR721069672106962015-08-30
03596010505170SCULPTOR721069572106952015-08-30
03596010505194SCULPTOR721070072107002015-08-30
00885554016703560P72202351722023512015-08-29
00885556919781Real IntelligenceROB30007ROB300072026-10-13
00885556924327Real IntelligenceROB30801ROB308012026-10-08
03596010445803NA720903072090302015-08-30
03596010470294SAPHYRE720968472096842015-08-30
03596010470331ABLATOR720965972096592015-08-30
03596010470348ABLATOR720965872096582015-08-30
03596010470416ABLATOR720965172096512015-08-30
03596010470577ABLATOR720965072096502015-08-30
03596010470614TAC-S720963272096322015-08-30
03596010448446TWINFIX720910972091092015-08-30
03596010470393ABLATOR720965372096532015-08-30
03596010470423ABLATOR720964972096492015-08-30
03596010510976NA721004072100402015-08-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776429133MillenniumAvalign Technologies, Inc.GJC2026-09-04
00842180198562ELMEDELMED INCORPORATEDGJC2024-04-23
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