FDA.reportPublic FDA data

Snowden-Pencer

Primary DI
00724995268343
Brand
Snowden-Pencer
Company
STERIS Deutschland GmbH
Model
885053
Catalog number
885053
Device description
Snowden-Pencer ENDOPLASTIC DISSECTOR HALF CURVED, EXTRA SHARP TIP 9-1/4 inches 23.5CM
Published
2026-09-25
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, general & plastic surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K930667000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K930667000REUSABLE LAPAROSCOPIC INSTRUMENTSSnowden-Pencer1994-05-16GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885403152986PreviousGS10
00724995268343PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088540315298610885403152986
00724995268343007249952683437249952683430724995268343

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery dissectorA hand-held surgical instrument, usually spoon-shaped or rounded at the working end, used to separate a soft tissue or body structure from another. It is used in general or plastic surgery and is usually designed with a handle which continues into a shaft that terminates at the distal end with a tip. The tip may be pointed or flat, sharp or blunt, and angled or straight from the shaft. It is made of high-grade stainless steel, comes in various shapes and sizes. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
537625100
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724995266936Snowden-Pencer8810258810252026-10-15
00724995267391Snowden-Pencer8814258814252026-10-15
00724995267407Snowden-Pencer8814268814262026-10-15
00724995267414Snowden-Pencer8814278814272026-10-15
00724995267421Snowden-Pencer8814308814302026-10-15
00724995267445Snowden-Pencer8814328814322026-10-15
00724995267452Snowden-Pencer8814358814352026-10-15
00724995267469Snowden-Pencer8814418814412026-10-15
00724995267476Snowden-Pencer8814428814422026-10-15
00724995267933Snowden-Pencer8831038831032026-10-15
00724995268053Snowden-Pencer8838908838902026-10-15
00724995268060Snowden-Pencer8838918838912026-10-15
00724995268190Snowden-Pencer8840328840322026-10-15
00724995268206Snowden-Pencer8840338840332026-10-15
00724995268213Snowden-Pencer8840348840342026-10-15
00724995268220Snowden-Pencer8840358840352026-10-15
00724995317607V. MuellerOP190OP1902026-10-15
00724995317638V. MuellerOP191OP1912026-10-15
00724995317645V. MuellerOP192OP1922026-10-15
00724995317652V. MuellerOP193OP1932026-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04548736175013OLYMPUSSONY CORPORATIONGCJ2026-10-15
04548736175068OLYMPUSSONY CORPORATIONGCJ2026-10-15
04548736175112OLYMPUSSONY CORPORATIONGCJ2026-10-15
00190776434922MillenniumAvalign Technologies, Inc.GCJ2026-10-14
00190776434823MillenniumAvalign Technologies, Inc.GCJ2026-10-13
00190776434854MillenniumAvalign Technologies, Inc.GCJ2026-10-13
B382SD56300680Surgical DirectSurgical Direct, Inc.GCJ2026-10-13
B382SD563006820Surgical DirectSurgical Direct, Inc.GCJ2026-10-13
00190776434250MillenniumAvalign Technologies, Inc.GCJ2026-10-09
00848657078481AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GCJ2026-10-08
00848657078498AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GCJ2026-10-08
00190776433697MillenniumAvalign Technologies, Inc.GCJ2026-10-07
00190776433703MillenniumAvalign Technologies, Inc.GCJ2026-10-07
00190776433710MillenniumAvalign Technologies, Inc.GCJ2026-10-07
00190776433727MillenniumAvalign Technologies, Inc.GCJ2026-10-07
00190776433338MillenniumAvalign Technologies, Inc.GCJ2026-10-05
00190776433345MillenniumAvalign Technologies, Inc.GCJ2026-10-05
00190776433031MillenniumAvalign Technologies, Inc.GCJ2026-10-01
00190776433079MillenniumAvalign Technologies, Inc.GCJ2026-10-01
00190776432911MillenniumAvalign Technologies, Inc.GCJ2026-09-30
00190776432928MillenniumAvalign Technologies, Inc.GCJ2026-09-30
B382SD13768330Surgical DirectSurgical Direct, Inc.GCJ2026-09-30
B382SD9156321100Surgical DirectSurgical Direct, Inc.GCJ2026-09-30
B382SD49195170Surgical DirectSurgical Direct, Inc.GCJ2026-09-29
B382SD9039841050Surgical DirectSurgical Direct, Inc.GCJ2026-09-29
00724995268312Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268329Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268336Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268350Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268374Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25