FDA.reportPublic FDA data

Snowden-Pencer

Primary DI
00724995268220
Brand
Snowden-Pencer
Company
STERIS Deutschland GmbH
Model
884035
Catalog number
884035
Device description
Snowden-Pencer DIAMOND-TIP OSTEOTOMES SHEEHAN 16CM 6-1/4 inches, 5MM
Published
2026-10-15
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
EMMCHISEL, OSTEOTOME, SURGICAL

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885403152771PreviousGS10
00724995268220PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088540315277110885403152771
00724995268220007249952682207249952682200724995268220

GMDN Terms#

Term, Definition table
TermDefinition
Plastic surgery osteotomeA surgical, chisel-like, instrument designed to cut and/or shape small bones and/or cartilage during plastic surgery. It is hand-held by the surgeon who will typically use a surgical mallet or hammer to manually impart an impacting force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, often flat, but can be curved (concave) in design, and is typically bevelled on either side with sloping curves. This device will be made of high-grade stainless steel and be used for plastic surgery procedures (e.g., to shape nasal cartilage). 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
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
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
00724995317607V. MuellerOP190OP1902026-10-15
00724995317638V. MuellerOP191OP1912026-10-15
00724995317645V. MuellerOP192OP1922026-10-15
00724995317652V. MuellerOP193OP1932026-10-15
10724995269316Snowden-Pencer8891138891132026-10-15

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
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
04099797013108SCREW-LINE OsteotomeALTATEC GmbHEMM2026-08-17