FDA.reportPublic FDA data

AESCULAP

Primary DI
04046963806941
Brand
AESCULAP
Company
Aesculap AG
Model
SX631T
Catalog number
SX631T
Device description
S4C OCCIPUT ACCESS PLATE SCREW 5.5X11MM
Published
2014-09-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NKBOrthosis, spinal pedicle fixation, for degenerative disc disease

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046963806941PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046963806941040469638069414046963806941

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(888)229-3002setworld_orders@aesculap.com

Regulatory Flags#

DUNS number
315018218
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04038653177028AESCULAPOG962ROG962R2016-09-23
04038653177042AESCULAPOG964ROG964R2016-09-23
04046964694165AESCULAPPL741SUPL741SU2016-09-23
04046964809392AESCULAPPL739SUPL739SU2016-10-10
04046964810411AESCULAPPL743SUPL743SU2016-10-10
04038653434022AESCULAPFT944TFT944T2015-09-24
04046963417468AESCULAPFT942TFT942T2015-09-24
04038653042586AESCULAPET251RET251R2016-09-23
04046964227547AESCULAPGF058BGF058B2016-09-23
04038653148998AESCULAPDO706RDO706R2020-04-21
04038653105878AESCULAPLS059RLS059R2020-04-21
04038653106080AESCULAPLS099RLS099R2020-04-21
04038653034666AESCULAPDE419RDE419R2020-06-17
04038653034697AESCULAPDE422RDE422R2020-06-17
04038653105977AESCULAPLS084RLS084R2022-07-29
04038653199020AESCULAPXG105RXG105R2021-10-15
04038653199006AESCULAPXG103RXG103R2020-08-24
04038653199013AESCULAPXG104RXG104R2020-08-24
04038653460533AESCULAPXG106RXG106R2020-08-24
04046963000431AESCULAPXG107RXG107R2020-08-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157124618ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124625ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124632ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124649ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124656ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124663ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124670ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124687ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124694ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124700ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124717ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124724ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124731ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124748ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124755ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124762ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124779ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124786ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124793ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124809ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124816ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124823ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124830ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124847ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124854ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124861ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124878ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124885ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124892ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124908ZAVATION SCREWZavation LLCNKB2026-11-04