FDA.reportPublic FDA data

Symmetry Surgical®

Primary DI
00887482134351
Brand
Symmetry Surgical®
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
45-5101
Catalog number
45-5101
Device description
Symmetry® Forceps, Aggressive Grasping, 45 cm
Published
2018-09-25
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K940552000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K940552000MONOPOLAR SURGICAL INSTRUMENTSTnco, Inc.1994-05-05GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887482134351PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887482134351008874821343518874821343510887482134351

GMDN Terms#

Term, Definition table
TermDefinition
Rigid endoscopic tissue manipulation forceps, reusableA rigid, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope and/or an endoscopic port (e.g., laparoscopic port) primarily for grasping and manipulating tissues during endoscopic surgery. It has proximal controls (e.g., scissors-like handles), a rigid long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
027680821
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00840113244232ValleylabE15594E155942026-05-04
00840113244249ValleylabE15596E155962026-05-04
00840113244256ValleylabE15604E156042026-05-04
00840113244263ValleylabE15606E156062026-05-04
00840113244270ValleylabE15614E156142026-05-04
00840113244287ValleylabE15616E156162026-05-04
00840113244294ValleylabE15624E156242026-05-04
00840113244300ValleylabE15626E156262026-05-04
00840113244317ValleylabE15644E156442026-05-04
00840113244324ValleylabE15646E156462026-05-04
00840113244331ValleylabE16512 E16512 2026-05-04
00840113244348ValleylabE16514E165142026-05-04
00887482188873BovieA23502024-09-27
00887482188897BovieA33502024-09-27
00887482181324BovieIDS-2102024-08-26
00887482181508BovieIDS-3102024-08-26
00887482182536BovieA9422024-08-26
00887482182550BovieA9522024-08-26

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