FDA.reportPublic FDA data

Snowden-Pencer

Primary DI
10885403482557
Brand
Snowden-Pencer
Company
STERIS CORPORATION
Model
SP8306
Catalog number
SP8306
Device description
ERGONOMIC MODULAR ATRAUMATIC GRASPER D/A 5MM, 36CM INSERT, 14MM JAW ESU
Published
2018-12-03
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
GCJLaparoscope, general & plastic surgery

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151036000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151036000Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol Grip Laparoscopic InstrumentsCarefusion 2200, Inc.2016-02-01GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885403482557PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088540348255710885403482557

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)323-9088Customer_Support@BD.com
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
021599373
Device count
1
DM exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885403096372V. MuellerOP26-001OP260012018-09-07
10885403096389V. MuellerOP26-002OP260022018-09-07
10885403096396V. MuellerOP26-003OP260032018-09-07
10885403096402V. MuellerOP27OP272018-09-07
10885403096426V. MuellerOP50OP502018-09-07
10885403096310V. MuellerOP10OP102018-09-07
10885403096327V. MuellerOP20OP202018-09-07
10885403096341V. MuellerOP24OP242018-09-07
10885403096365V. MuellerOP26OP262018-09-07
10885403096419V. MuellerOP30OP302018-09-07
10885403096433V. MuellerOP60OP602018-09-07
10885403096440V. MuellerOP70OP702018-09-07
10885403096457V. MuellerOP80OP802018-09-07
10885403096471V. MuellerOP112OP1122018-09-07
10885403096488V. MuellerOP113OP1132018-09-07
10885403096495V. MuellerOP120OP1202018-09-07
10885403096518V. MuellerOP160OP1602018-09-07
10885403096686V. MuellerOP330OP3302018-09-07
10885403132377V. MuellerSU3147SU31472018-09-18
10885403132384V. MuellerSU3148SU31482018-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048551158913n.a.Karl Storz GmbH & Co. KGGCJ2026-11-04
04048551158937n.a.Karl Storz GmbH & Co. KGGCJ2026-11-04
04251303804093TrokamedTROKAMED GmbHGCJ2026-11-03
04251303804116TrokamedTROKAMED GmbHGCJ2026-11-03
04251303808916TrokamedTROKAMED GmbHGCJ2026-11-03
04251303809036TrokamedTROKAMED GmbHGCJ2026-11-03
04251303809043TrokamedTROKAMED GmbHGCJ2026-11-03
04251303809050TrokamedTROKAMED GmbHGCJ2026-11-03
04251303809067TrokamedTROKAMED GmbHGCJ2026-11-03
04251303809074TrokamedTROKAMED GmbHGCJ2026-11-03
04251303810933TrokamedTROKAMED GmbHGCJ2026-11-03
04251303817611TrokamedTROKAMED GmbHGCJ2026-11-03
04048551431603n.a.Karl Storz GmbH & Co. KGGCJ2026-11-02
08904332600803MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGCJ2026-11-02
B382SD13108150Surgical DirectSurgical Direct, Inc.GCJ2026-10-30
B382SD15908450Surgical DirectSurgical Direct, Inc.GCJ2026-10-30
B382SD32154290Surgical DirectSurgical Direct, Inc.GCJ2026-10-30
B382SD13517450Surgical DirectSurgical Direct, Inc.GCJ2026-10-28
B382SD13518130Surgical DirectSurgical Direct, Inc.GCJ2026-10-28
B382SD15908130Surgical DirectSurgical Direct, Inc.GCJ2026-10-28
B382SD77505940Surgical DirectSurgical Direct, Inc.GCJ2026-10-28
00190776436827MillenniumAvalign Technologies, Inc.GCJ2026-10-22
B382SD772553050Surgical DirectSurgical Direct, Inc.GCJ2026-10-22
00190776435677MillenniumAvalign Technologies, Inc.GCJ2026-10-21
00190776435684MillenniumAvalign Technologies, Inc.GCJ2026-10-21
00190776435493MillenniumAvalign Technologies, Inc.GCJ2026-10-20
00190776435547MillenniumAvalign Technologies, Inc.GCJ2026-10-20
00190776435295MillenniumAvalign Technologies, Inc.GCJ2026-10-19
00190776435455MillenniumAvalign Technologies, Inc.GCJ2026-10-19
B354OSCVORTH80Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19