FDA.report

STINGRAY SURGICAL PRODUCTS

Primary DI
B112G50258I0
Brand
STINGRAY SURGICAL PRODUCTS
Company
STINGRAY SURGICAL PRODUCTS, LLC
Model
G50-258I
Catalog number
258I
Device description
Deaver Retractor Insulated, Length 7.0" (17.8cm), Width 0.75" (1.9cm), Stainless Steel
Published
2021-05-19
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
GEGElevator, Surgical, General & Plastic Surgery

Product Code Classifications

CodeDeviceSpecialtyClass
GEGElevator, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B112G50258I0PrimaryHIBCC0

GMDN Terms

TermDefinition
Hand-held surgical retractor, reusableA hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(561)210-7582udi@stingraysurgical.com

Regulatory Flags

DUNS number
024328124
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
B112S03240FGU45Z0STINGRAY SURGICAL PRODUCTSS03-240FGU45Z2023-11-07
B112S03240FGZ0STINGRAY SURGICAL PRODUCTSS03-240FGZ2023-11-07
B112S031390NS0STINGRAY SURGICAL PRODUCTSS031-390NSS031-390NS2021-05-25
B112G030080STINGRAY SURGICAL PRODUCTSG03-008G03-0082021-05-20
B112G030100STINGRAY SURGICAL PRODUCTSG03-010G03-0102021-05-20
B112G030120STINGRAY SURGICAL PRODUCTSG03-012G03-0122021-05-20
B112G030140STINGRAY SURGICAL PRODUCTSG03-014G03-0142021-05-20
B112G030160STINGRAY SURGICAL PRODUCTSG03-016G03-0162021-05-20
B112G030180STINGRAY SURGICAL PRODUCTSG03-018G03-0182021-05-20
B112G031060STINGRAY SURGICAL PRODUCTSG03-106G03-1062021-05-20
B112G031080STINGRAY SURGICAL PRODUCTSG03-108G03-1082021-05-20
B112G031100STINGRAY SURGICAL PRODUCTSG03-110G03-1102021-05-20
B112G031120STINGRAY SURGICAL PRODUCTSG03-112G03-1122021-05-20
B112G031140STINGRAY SURGICAL PRODUCTSG03-114G03-1142021-05-20
B112G031160STINGRAY SURGICAL PRODUCTSG03-116G03-1162021-05-20
B112G031180STINGRAY SURGICAL PRODUCTSG03-118G03-1182021-05-20
B112G032060STINGRAY SURGICAL PRODUCTSG03-206G03-2062021-05-20
B112G032080STINGRAY SURGICAL PRODUCTSG03-208G03-2082021-05-20
B112G032100STINGRAY SURGICAL PRODUCTSG03-210G03-2102021-05-20
B112G032120STINGRAY SURGICAL PRODUCTSG03-212G03-2122021-05-20

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00810123209743Adler Instrument CompanyAdler, Inc.GEG2026-01-02
00841336106802Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCGEG2025-12-22
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B382SD91010Surgical DirectSurgical Direct, Inc.GEG2025-12-02
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