FDA.report

Symmetry Surgical®

Primary DI
00887482174708
Brand
Symmetry Surgical®
Company
SYMMETRY SURGICAL INC.
Model
51-1501
Catalog number
51-1501
Device description
Symmetry® Scoop, Ferguson Gall Stone, Double-Ended, 9 mm & 11 mm, Small, 9 1/2 in
Published
2024-08-15
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
FHLScoop

Product Code Classifications

CodeDeviceSpecialtyClass
FHLScoopGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00887482174708PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00887482174708008874821747088874821747080887482174708

GMDN Terms

TermDefinition
Gallstone scoopA hand-held manual surgical instrument designed for the removal of gallstones. It is typically made of high-grade stainless steel and has a very long, thin, malleable (bendable) working end that terminates in a small spoon-like scoop. At the proximal end is a handle used by the surgeon to manipulate and operate the instrument during the removal procedure. It can have a variety of scoop designs. This is a reusable device.

Device Sizes

TypeValueUnit
Circumference9Millimeter
Circumference11Millimeter
Length9.5Inch

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1 888-364-7004customerservice@symmetrysurgical.com

Regulatory Flags

DUNS number
079641356
Device count
1
DM exempt
true
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
false
Sterilization required before use
true

Other Devices From This Company

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00887482012307Symmetry Tyrell 38-652538-65252022-09-16
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00887482030578Symmetry Hardy80-133080-13302024-09-05
00887482030585Symmetry Hardy80-133180-13312024-09-05
00887482030592Symmetry Hardy80-133280-13322024-09-05
00887482030608Symmetry Hardy80-133380-13332024-09-05
00887482030615Symmetry Hardy80-133480-13342024-09-05
00887482030622Symmetry Hardy80-133580-13352024-09-05
00887482030707Symmetry Hardy80-134580-13452024-09-05
00887482030714Symmetry Hardy80-134680-13462024-09-05
00887482030721Symmetry Hardy80-134780-13472024-09-05
00887482030738Symmetry Hardy80-134880-13482024-09-05
00887482031124Symmetry Verity™80-153680-15362024-09-05
00887482031506Symmetry Rhoton®80-169280-16922024-09-05
00887482031513Symmetry Rhoton®80-169380-16932024-09-05
00887482116203Symmetry Paparella61-377561-37752024-09-05

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