FDA.report

Savary Gilliard

Primary DI
00827002572829
Brand
Savary Gilliard
Company
COOK INCORPORATED
Model
G57282
Catalog number
SGW-360-SD-D
Device description
Savary Gilliard Wire Guide
Published
2019-04-26
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
true

Related Records

Contact Domains

Product Codes

CodeName
KNQDilator, esophageal

Product Code Classifications

CodeDeviceSpecialtyClass
KNQDilator, EsophagealGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00827002572829PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002572829008270025728298270025728290827002572829

GMDN Terms

TermDefinition
Gastro-urological guidewire, single-useA sterile metal coil or wire intended to assist the insertion/positioning of a diagnostic/therapeutic device(s) [e.g., endoscope, catheter] within the gastrointestinal (GI) and/or urinary tract. It is typically coated with a plastic material [e.g., polytetrafluoroethylene (PTFE), commonly known as Teflon, or polyethylene (PE)]. It may have radiopaque graduated markings at the distal end to assist in the fluoroscopic monitoring of its advancement/position within the body. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store in dark, dry, cool place.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(812)330-5494sharedservices@cookmedical.com

Regulatory Flags

DUNS number
079720472
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00827002613508SureTome SWG61350SUR-SW-352025-12-08
10827002613512SureTome SWG61351SUR-SW-AWG2-35-2602025-12-08
10827002613529SureTome SWG61352SUR-SW-AWG2-35-4502025-12-08
10827002242378BakriG24237J-SOSR-1005002016-09-24
10827002306735BakriG30673J-SOS-1005002016-09-24
00827002607842COOKG60784TESLA-B2535-2602025-07-22
00827002607859COOKG60785TESLA-B2535-4502025-07-22
10827002597508COOKG59750TESLA-B-ACU2025-07-11
10827002496535Cotton-Leung Sof-FlexG49653CLSO-SF-10-52015-11-03
00827002352674HerculesG35267HBDE-W-8-9-102022-12-20
00827002352681HerculesG35268HBDE-W-10-11-122022-12-20
00827002352698HerculesG35269HBDE-W-12-13.5-152022-12-20
00827002352704HerculesG35270HBDE-W-15-16.5-182022-12-20
00827002352711HerculesG35271HBDE-W-18-19-202022-12-20
10827002346014FusionG34601FS-OMNI-ACRO-35-2052016-09-24
10827002346939FusionG34693FS-OMNI-ACRO-35-2602016-09-24
10827002347110FusionG34711FS-OMNI-ACRO-35-4502016-09-24
10827002347783D.A.S.H.G34778DASH-ACRO-35-4502016-09-24
10827002347790D.A.S.H.G34779DASH-ACRO-25-4502016-09-24
10827002347806D.A.S.H.G34780DASH-ACRO-35-2602016-09-24

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
04260206311966BougieCap POvesco Endoscopy AGKNQ2026-01-16
56932503524013Rapide(TM) Multistage Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.KNQ2025-12-06
56932503524020Rapide(TM) Multistage Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.KNQ2025-12-06
56932503524037Rapide(TM) Multistage Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.KNQ2025-12-06
56932503524044Rapide(TM) Multistage Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.KNQ2025-12-06
56932503524051Rapide(TM) Multistage Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.KNQ2025-12-06
56932503524068Rapide(TM) Multistage Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.KNQ2025-12-06
56932503524075ABC Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.KNQ2025-12-06
56932503524082ABC Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.KNQ2025-12-06
56932503524099ABC Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.KNQ2025-12-06
56932503524105ABC Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.KNQ2025-12-06
56932503524129ABC Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.KNQ2025-12-06
56932503524143ABC Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.KNQ2025-12-06
56932503524150ABC Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.KNQ2025-12-06
00724995244545LumiflexUS EndoscopyKNQ2025-06-03
00724995244552LumiflexUS EndoscopyKNQ2025-06-03
00724995244569LumiflexUS EndoscopyKNQ2025-06-03
00724995244583LumiflexUS EndoscopyKNQ2025-06-03
00724995244590LumiflexUS EndoscopyKNQ2025-06-03
00724995244613LumiflexUS EndoscopyKNQ2025-06-03
00724995244644LumiflexUS EndoscopyKNQ2025-06-03
00724995244668LumiflexUS EndoscopyKNQ2025-06-03
00724995244675LumiflexUS EndoscopyKNQ2025-06-03
00724995244682LumiflexUS EndoscopyKNQ2025-06-03
16932503520673Disposable Dilation BalloonMicro-Tech (Nanjing) Co., Ltd.KNQ2025-04-30
16932503520680Disposable Dilation BalloonMicro-Tech (Nanjing) Co., Ltd.KNQ2025-04-30
16932503520697Disposable Dilation BalloonMicro-Tech (Nanjing) Co., Ltd.KNQ2025-04-30
16932503520765Disposable Dilation BalloonMicro-Tech (Nanjing) Co., Ltd.KNQ2025-04-30
16932503520772Disposable Dilation BalloonMicro-Tech (Nanjing) Co., Ltd.KNQ2025-04-30
16932503520789Disposable Dilation BalloonMicro-Tech (Nanjing) Co., Ltd.KNQ2025-04-30