FDA.reportPublic FDA data

Snowden-Pencer

Primary DI
10885403152764
Brand
Snowden-Pencer
Company
STERIS CORPORATION
Model
88-4034
Catalog number
884034
Device description
Snowden-Pencer DIAMOND-TIP OSTEOTOMES SHEEHAN 16CM 6-1/4 inches, 4MM
Published
2018-07-13
Public version status
Update
Distribution status
Not 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
EMMCHISEL, OSTEOTOME, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMMChisel, Osteotome, SurgicalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885403152764PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088540315276410885403152764

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
021599373
Device count
1
DM exempt
false
Premarket exempt
true
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
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
00724995268190Snowden-PencerSTERIS Deutschland GmbHEMM2026-10-15
00724995268206Snowden-PencerSTERIS Deutschland GmbHEMM2026-10-15
00724995268213Snowden-PencerSTERIS Deutschland GmbHEMM2026-10-15
00724995268220Snowden-PencerSTERIS Deutschland GmbHEMM2026-10-15
00190776432836MillenniumAvalign Technologies, Inc.EMM2026-09-29
G879OSTCVC220DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCVC270DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCVC320DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCVC370DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCVC420DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCVS220DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCVS270DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCVS320DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCVS370DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCVS420DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCXC220DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCXC270DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCXC320DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCXC370DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCXC420DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCXS220DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCXS270DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCXS320DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCXS370DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCXS420DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
04099797012989SCREW-LINE Osteotomy setALTATEC GmbHEMM2026-08-17
04099797012996SCREW-LINE Osteotomy setALTATEC GmbHEMM2026-08-17
04099797013016SCREW-LINE OsteotomeALTATEC GmbHEMM2026-08-17
04099797013047SCREW-LINE OsteotomeALTATEC GmbHEMM2026-08-17
04099797013078SCREW-LINE OsteotomeALTATEC GmbHEMM2026-08-17