FDA.reportPublic FDA data

Symmetry Stille-Luer

Primary DI
00887482068885
Brand
Symmetry Stille-Luer
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
31-3024
Catalog number
31-3024
Device description
Symmetry® Rongeur, Bone Double/A, Straight, 9 in
Published
2024-06-28
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
HAERongeur, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAERongeur, ManualNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K081651000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081651000INSTRUMED RONGEURInstrumed International, Inc.2008-08-08HAE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887482068885PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887482068885008874820688858874820688850887482068885

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length9Inch

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1 888-364-7004customerservice@symmetrysurgical.com

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
00887482049938Symmetry Surgical55-868055-86802018-09-25
00887482049945Symmetry Surgical55-868155-86812018-09-25
00887482049952Symmetry Surgical55-868255-86822018-09-25
00887482049969Symmetry Surgical55-868355-86832018-09-25
00887482090282Symmetry Surgical55-868455-86842018-09-25
00887482090299Symmetry Surgical55-868555-86852018-09-25
00840113235445Bovie Fluoro-Dot68022026-10-21
00840113233915RN-Pack66RN2026-10-20
00840113233939High Intensity Medical Penlights Disposable66662026-10-20
00840113235438Diagnostic Medical Penlights63032026-10-20
00840113236367BovieUV592026-10-20
00887482156667Symmetry53-1675RC2026-09-29
10840113232908BovieAA002026-09-21
10840113232922BovieAA00X2026-09-21
10840113232946BovieAA012026-09-21
10840113232960BovieAA01X2026-09-21
10840113232984BovieAA022026-09-21
10840113233004BovieAA032026-09-21
10840113233028BovieAA03X2026-09-21
10840113233042BovieAA042026-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776439880MilleniumAvalign Technologies, Inc.HAE2026-11-05
00190776439897MilleniumAvalign Technologies, Inc.HAE2026-11-05
00190776440879MilleniumAvalign Technologies, Inc.HAE2026-11-05
00190776439835MilleniumAvalign Technologies, Inc.HAE2026-10-28
B382SD9228132210Surgical DirectSurgical Direct, Inc.HAE2026-10-20
B382SD9228132220Surgical DirectSurgical Direct, Inc.HAE2026-10-20
00840217900089Wiggins MedicalEBNER MEDICAL, LLCHAE2021-03-29
00840217900096Ace MedicalEBNER MEDICAL, LLCHAE2021-03-29
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